Official recall notice
FDA DeviceClass IINotable
FDA Recall: One Step P in vitro diagnostic test REF: 8194
- Recall date
- 2026-05-13
- Brand
- DFI Co., Ltd.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The devices were distributed without required FDA premarket clearance or approval.
Recommended action
What to do
1064 units
Product description
The devices were distributed without required FDA premarket clearance or approval.